DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 14 is objected to because of the following informalities: in line 2 between the words: “along” and “center”, the word ---the--- must be entered. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-13 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/013856 A1.
‘856 discloses a fixation system for engaging tissue of a patient, comprising: a delivery device having a shaft (623) defining a lumen extending from a first end to a second end of the shaft; an implantable fixation device (17A and 17B) having a first clamp, a second clamp, and a center portion connected to and extending between the first and second clamps, the center portion being releasably connected to a distal end of the shaft of the delivery device (see Figs. 17A-B disconnected from the catheter). The first clamp defining a first lateral extent of the fixation device, and the second clamp defining a second lateral extent of the fixation device; and a first optical coherence tomography (“OCT”) catheter configured for cardiovascular imaging having a first imaging probe comprising a first end, a second end, and a first lens (inherent) assembly disposed at the second end of the first imaging probe, the first imaging probe being configured to transmit light between the first and second ends thereof, wherein, in an assembled condition of the fixation system, the first imaging probe extends through the lumen and out from the second end of the shaft such that the first lens assembly is positioned between the first and second lateral extents of the fixation device (see paragraph 231-232). See Figs. 18E and 19.
Regarding claim 2, see paragraph 232 and Figs. 18E and 19.
Regarding claim 3, the device is capable of being rotatable and translatable, since element 834 in Fig. 19 is deployed through a lumen along the length of the catheter.
Regarding claim 4, see paragraph 165 disclosing a flush feature.
Regarding claim 7, see Figures 2L and 2M showing the handle connected to the shaft and having a OCT probe interface.
Regarding claim 8, see Fig. 9C and paragraph 49 disclosing the plurality of lumens and the actuator rod configured to move the clamps.
Regarding claim 9, see figure below showing the two planes. The Examiner wants to point out that the planes have been randomly selected so it can read on the claimed subject matter.
Regarding claims 10 and 11, see figure below, OCT probe inherently comprise lens, as disclosed by the specification the OCT probe can be connected at the end of a retractable and steerable shaft (834), therefore, the shaft (834) is capable of being adjacent to the center portion and is capable of being positioned in the first and/or the second plane intercepting the first lens assembly. NOTE: claim 10 is just claiming the position of the first lens relative to the center portion. The Examiner just needs to find a reference capable of being positioned in the center portion.
Regarding claim 12, see figure below showing the four quadrants and the first lens assembly being positioned adjacent to the center portion.
Regarding claims 18 and 20, paragraph 231 discloses that a multitude of probes can be used during the reference procedure and are capable of being positioned between the first and second lateral extends. Additionally, the Oct probe is capable of intersecting 50% of the maximum leaflet insertion depth of the first and second clamps.
Regarding claim 19, see Figs. 17A-B.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/013856 A1 in view of Petersen et al US Patent 7,813,609 B2.
‘856 discloses the invention substantially as claimed. However, ‘856 is silent regarding a beam deflector configured to deflect the beam at a perpendicular angle relative to the central axis of the probe.
Petersen et al discloses a catheter having a OCT probe at the end of the shaft, the OCT probe comprises a beam reflector configured to deflect the light perpendicular to the axis of the probe for the purpose of providing radial scan inside the lumen.
It would have been obvious to one ordinary skill in the art to modify the OCT probe of the ‘856 reference by adding a beam reflector in order to provide radial scan inside the lumen.
Allowable Subject Matter
Claims 14-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 9/15/26
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